Test strip container with integrated meter having strip coding capability

• US 20060189895A1
• Filed: 02/13/2006
• Published: 08/24/2006
• Est. Priority Date: 12/31/2003
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Modzelewski, Brent E., Oti, Carlos, Caban, Allan Javier, Neel, Gary T., Will, Adam Mark, Rounds, George R., Casterline, Cameron Scott
• Granted Patent: US 8,394,328 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150816 by tactile feedback, e.g. vibration
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/48771 : Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/521 : Single-layer analytical elements
• CPC Class Codes: G01N 35/00732 : Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 : for local operation

Abstract

A system for diagnostic testing may include a meter for performing a test on a sample applied to a test media and a selectively closable container configured to house test media compatible with the meter. The system may also provide mechanisms for removing a meter from a test container and reattaching it to a new one using one of several coding methods that recalibrate the meter for the new container of test strips. Alternatively, the system may include an auto-calibration system where data is provided individually on each individual test medium in a form readable by the test meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so as to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information. In addition, the system may further provide mechanisms to reconfigure the meter to perform a new function when it has been determined that a triggering event has occurred.

Claims

1. A system for diagnostic testing, the system comprising:

a meter for performing a diagnostic test on a sample applied to test media, the meter having a housing, the meter comprising;

an interface for accepting test media in order to perform the diagnostic test; and

a controller configured to perform the diagnostic test;

a container operatively associated with the meter and configured to contain test media compatible with the meter, the container having an opening; and

test media initially stored in the container and comprising at least one test strip embedded with a code readable by the controller to identify data particular to the test strip.

2. The system of claim 1, further comprising a light source positioned to illuminate an interior of the container.

3. The system of claim 1, wherein the at least one test strip includes a conductive pattern including electrical contacts disposed at a distal region of the strip forming a distinct pattern representing the code readable by the controller to identify data particular to the test strip.

4. The system of claim 1, wherein the at least one test strip includes a code pattern representing the code readable by the controller to identify data particular to the test strip.

5. The system of claim 1, wherein the at least one test strip includes a colored pattern representing the code readable by the controller to identify data particular to the test strip.

6. The system of claim 3, wherein the at least one test strip comprises:

at least one electrically insulating layer upon which the conductive pattern is formed; and

wherein each of the electrical contacts is selectively coverable with a discrete portion of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the code readable by the controller to identify data particular to the test strip.

7. The system of claim 3, wherein the electrical contacts are configured for contact, when inserted into the meter interface, with a plurality of contacts within the meter interface.

8. The system of claim 7, wherein at least one of the electrical strip contacts include a resistive element disposed thereon to form part of the distinct pattern readable by the meter upon insertion of the test strip into the meter interface.

9. The system of claim 1, wherein the code is utilized by the meter to access particular calibration parameters stored therein related to the particular test strip.

10. The system of claim 1, wherein the code is utilized by the meter to perform a particular measurement corresponding to the particular type of test strip.

11. The system of claim 1, wherein the code is utilized by the meter to access particular calibration parameters stored therein related to an entire particular test strip lot.

12. A system for diagnostic testing, the system comprising:

a meter for performing a diagnostic test on a sample applied to test media, the meter having a housing, the meter comprising;

an interface for accepting test media in order to perform the diagnostic test; and

a controller configured to perform the diagnostic test;

a container operatively associated with the meter and configured to contain test media compatible with the meter, the container having an opening;

test media initially stored in the container, the test media comprising at least one diagnostic test strip comprising;

at least one electrically insulating layer;

a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode; and

wherein each of the electrical strip contacts is selectively coverable with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable by the controller to identify data particular to the test strip.

13. The system of claim 12, wherein the at least one test strip includes a bar-code pattern representing the code readable by the controller to identify data particular to the test strip.

14. The system of claim 12, wherein the at least one test strip includes a colored pattern representing the code readable by the controller to identify data particular to the test strip.

15. The system of claim 12, further comprising at least one discrete portion of electrical insulating material disposed over at least one of the electrical strip contacts to at least partially form a distinct pattern readable by the controller to identify data particular to the test strip.

16. The system of claim 12, wherein the distinct pattern readable to identify data particular to the test strip comprises an arrangement where none of the electrical strip contacts are covered with electrical insulating material.

17. The system of claim 15, wherein a resistive element is disposed over at least one of the electrical strip contacts to form part of the distinct pattern readable to identify data particular to the test strip.

18. The system of claim 12, wherein each of the at least one electrodes is individually connected to one contact in a first plurality of electrical strip contacts.

19. The system of claim 18, wherein the conductive pattern at the distal region of the strip includes a second plurality of electrical strip contacts.

20. The system of claim 19, wherein the first and second plurality of electrical strip contacts are positioned to form distinct groups of electrical contacts, the groups being spaced from one another.

21. The system of claim 19, wherein the second plurality of electrical strip contacts form a discrete set of contacting pads.

22. The system of claim 15, wherein the insulating material comprises a non-conductive insulating ink.

23. The system of claim 21, wherein the contacting pads are configured for contact, when inserted into a compatible meter, with a plurality of contacts in a corresponding connector of the meter.

24. A system for diagnostic testing, the system comprising:

a meter for performing a diagnostic test on a sample applied to test media, the meter comprising;

a housing;

an interface for accepting test media in order to perform the diagnostic test; and

a controller configured to perform the diagnostic test;

a container operatively associated with the meter and configured to contain test media compatible with the meter, the container having an opening;

test media initially stored in the container, the test media comprising at least one diagnostic test strip comprising;

at least one electrically insulating layer;

a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;

a reagent layer contacting at least a portion of at least one electrode;

a first plurality of electrical strip contacts comprised of contacts individually connected to an electrode;

a second plurality of electrical strip contacts comprised of the conductive pattern at the distal region of the strip; and

wherein an electrically insulating material separates the first and second plurality of electrical strip contacts.

25. The system of claim 24, wherein each of the electrical strip contacts comprising the second plurality is selectively coverable with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable by the controller to identify data particular to the test strip.

26. The system of claim 25, further comprising at least one discrete portion of electrical insulating material disposed over at least one of the electrical strip contacts to at least partially form a distinct pattern readable to identify data particular to the test strip.

27. The system of claim 25, wherein the distinct pattern readable to identify data particular to the test strip comprises an arrangement where none of the electrical strip contacts are covered with electrical insulating material.

28. The system of claim 26, wherein a resistive element is disposed over at least one of the electrical strip contacts to form part of the distinct pattern readable to identify data particular to the test strip.

29. The system of claim 24, wherein the second plurality of electrical strip contacts form a discrete set of contacting pads.

30. The system of claim 24, wherein the insulating material comprises a non-conductive insulating ink.

31. A system for diagnostic testing, the system comprising:

a meter for performing a diagnostic test on a sample applied to test media the meter comprising;

a housing;

an interface for accepting test media in order to perform the diagnostic test; and

a controller configured to perform the diagnostic test;

a container configured to contain test media compatible with the meter, the container having an opening;

test media initially stored in the container and comprising at least one test strip embedded with a code readable by the controller to identify data particular to the test strip; and

wherein the meter housing is configured to close the opening.

32. The system of claim 31, further comprising a light source positioned to illuminate an interior of the container.

33. The system of claim 31, wherein the at least one test strip includes a conductive pattern including electrical contacts disposed at a distal region of the strip forming a distinct pattern representing the code readable by the controller to identify data particular to the test strip.

34. The system of claim 31, wherein the at least one test strip includes a bar-code pattern representing the code readable by the controller to identify data particular to the test strip.

35. The system of claim 31, wherein the at least one test strip includes a colored pattern representing the code readable by the controller to identify data particular to the test strip.

36. The system of claim 33, wherein the at least one test strip comprises:

at least one electrically insulating layer upon which the conductive pattern is formed; and

wherein each of the electrical contacts is selectively coverable with a discrete portion of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the code readable by the controller to identify data particular to the test strip.

37. The system of claim 33, wherein the at least one test strip comprises:

at least one electrically insulating layer upon which the conductive pattern is formed; and

wherein each of the electrical contacts is selectively coverable with a discrete portion of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the code readable by the controller to identify data particular to the test strip.

38. The system of claim 33, wherein the electrical contacts are configured for contact, when inserted into the meter interface, with a plurality of contacts within the meter interface.

39. The system of claim 38, wherein at least one of the electrical strip contacts include a resistive element disposed thereon to form part of the distinct pattern readable by the meter upon insertion of the test strip into the meter interface.

40. The system of claim 31, wherein the code is utilized by the meter to access particular calibration parameters stored therein related to the particular test strip.

41. The system of claim 31, wherein the code is utilized by the meter to perform a particular measurement corresponding to the particular type of test strip.

42. The system of claim 31, wherein the code is utilized by the meter to access particular calibration parameters stored therein related to an entire particular test strip lot.

43. The system of claim 31, wherein the container comprises a holder configured to receive one or more devices used for diagnostic testing, and wherein the opening is accessible to a user of the system.

44. The system of claim 43, wherein the holder engages the meter.

45. The system of claim 43, wherein the holder engages a lancet.

46. A method of determining a constituent level within a fluid comprising:

providing a diagnostic test system comprising;

a meter for performing a diagnostic test, the meter comprising;

a housing;

an interface for accepting test media in order to perform the diagnostic test; and

a controller configured to perform the diagnostic test;

a container configured to contain test media compatible with the meter,

the container having an opening;

test media initially stored in the container and comprising at least one test strip embedded with a code readable by the controller; and

wherein the meter housing is configured to close the opening;

removing a test strip from the container;

inserting a first end of the strip into the meter interface;

applying a fluid sample at a second end of the strip;

reading the code embedded on the test strip with the controller;

identifying data particular to the test strip based on the code; and

calculating the fluid constituent concentration of the fluid sample with the controller.

47. The method of claim 46, further comprising closing the container with the meter housing.

48. The method of claim 46, further comprising illuminating an interior of the container with a light source.

49. The method of claim 46, further comprising providing the at least one test strip with a conductive pattern including electrical contacts disposed at a distal region of the strip forming a distinct pattern representing the code readable by the controller to identify data particular to the test strip.

50. The method of claim 46, further comprising providing the at least one test strip with a bar-code pattern representing the code readable by the controller to identify data particular to the test strip.

51. The method of claim 46, further comprising providing the at least one test strip with a colored pattern representing the code readable by the controller to identify data particular to the test strip.

52. The method of claim 49, wherein providing a diagnostic test system includes providing at least one electrically insulating layer on the test strip upon which the conductive pattern is formed;

and

wherein each of the electrical contacts is selectively coverable with a discrete portion of electrical insulating material to produce a binary code based on the number of electrical contacts, the resulting binary code representing the code readable by the controller to identify data particular to the test strip.

53. The method of claim 49, wherein inserting a first end of the strip into the meter interface includes connecting each of the electrical contacts on the strip with a plurality of corresponding contacts within the meter interface.

54. The method of claim 46, wherein identifying data particular to the test strip includes accessing particular calibration parameters stored in the meter related to the particular test strip.

55. The method of claim 46, wherein the code is utilized by the meter to perform a particular measurement corresponding to the particular type of test strip.

56. The method of claim 46, wherein identifying data particular to the test strip includes accessing particular calibration parameters stored in the meter related to an entire particular test strip lot.

57. The method of claim 46, wherein the code is read by the controller through an analog method.

58. The method of claim 46, wherein the code is read by the controller through a digital method.